BEUDAMED
    FDA Adverse Event Other Summary report: N

    JOHN HOPKINS BALTIMORE MD 1

    MDR report key: 2650416 · Received June 29, 2012

    Report

    Report Number
    1718850-2012-00681
    Event Type
    Other
    Date Received
    June 29, 2012
    Date of Event
    May 25, 2012
    Report Date
    June 2, 2012
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT THE VENT LINE DEVELOPED A SPLIT DURING A PROCEDURE. USE OF THE SPLIT LINE WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO PT INJURY. THE INVOLVED TUBING WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE VENT LINE DEVELOPED A SPLIT DURING A PROCEDURE. USE OF THE SPLIT LINE WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JOHN HOPKINS BALTIMORE MD 1 CUSTOMER PERFUSION PACK DWF SORIN GROUP USA, INC. NA 1211600026

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR